{"active_ingredient":["Active ingredient (in each chewable tablet) Loratadine USP, 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients."],"dosage_and_administration":["Directions chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["
adults and children 6 years and overchew 2 tablets daily; not more than 2 chewable tablets in 24 hours
children 2 to under 6 years of agechew 1 tablet daily; not more than 1 chewable tablet in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20240315","id":"10b4bbcb-dcd3-acc9-e063-6394a90a5daf","inactive_ingredient":["Inactive ingredients aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{"application_number":["ANDA210088"],"brand_name":["Dye-Free Childrens Loratadine"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["Ohm Laboratories Inc."],"package_ndc":["51660-112-31"],"product_ndc":["51660-112"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["665078"],"spl_id":["10b4bbcb-dcd3-acc9-e063-6394a90a5daf"],"spl_set_id":["9e9b2e1c-f565-42ef-9ec4-43bcebc549b7"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mg Tablet NDC 51660-112-31 † Compare to the active ingredient of Children's Claritin ® Chewable Ages 2+ years Children's Loratadine Chewable Tablets USP, 5 mg Antihistamine Indoor & Outdoor Allergies 30 CHEWABLE TABLETS The chewable tablets are to be chewed before swallowing. Dye-Free Bubble Gum Flavored Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. †Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. bg-30-ct"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984 . Keep the carton. It contains important information. See end panel for expiration date."],"recent_major_changes":[""],"set_id":"9e9b2e1c-f565-42ef-9ec4-43bcebc549b7","spl_product_data_elements":["Dye-Free Childrens Loratadine LORATADINE ASPARTAME ANHYDROUS CITRIC ACID SILICON DIOXIDE MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID LORATADINE LORATADINE white to off-white beveled edge 112"],"spl_unclassified_section":["Drug Facts","Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 0420"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["Other information phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25°C (68° to 77°F)."],"version":"3","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}